Nabi-HB 1560 [iU]/5mL
Hepatitis B Immune Globulin (Human) · LIQUID · ADMA Biologics, Inc.
Nabi-HB is a prescription liquid containing hepatitis b immune globulin (human) at 1560 [iU]/5mL, taken intramuscular. Manufactured by ADMA Biologics, Inc..
Key Facts
- Brand Name
- Nabi-HB
- Generic Name
- Hepatitis B Immune Globulin (Human)
- NDC Code (Product)
69800-4203- Manufacturer
- ADMA Biologics, Inc.
- Strength
- 1560 [iU]/5mL
- Dosage Form
- LIQUID
- Route
- INTRAMUSCULAR
- Marketing Status
- HUMAN PRESCRIPTION DRUG
- Application #
- BLA103945
- Drug Class
- Human Immunoglobulin [EPC]; Immunoglobulins [CS]
- Marketing Start
- 10/23/2001
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Nabi-HB, Hepatitis B Immune Globulin (Human), is indicated for treatment of acute exposure to blood containing HBsAg, perinatal exposure of infants born to HBsAg-positive mothers, sexual exposure to HBsAg-positive persons and household exposure to persons with acute HBV infec- tion in the following settings: Acute Exposure to Blood Containing HBsAg: Following either parenteral exposure (needlestick, bite, sharps), direct mucous membrane contact (accidental splash), or oral ingestion (pipetting accident), involving HBsAg-positive materials such as blood, plasma, or serum. Perinatal Exposure of Infants Born to HBsAg-positive Mothers: Infants born to mothers positive for HBsAg with or without HBeAg 12 . Sexual Exposure to HBsAg-positive Persons: Sexual partners of HBsAg-positive persons. Household Exposure to Persons with Acute HBV Infection: Infants less than 12 months old whose mother or primary caregiver is positive for HBsAg. Other household contacts with an identifiable blood exposure to the index patient. Nabi-HB is indicated for intramuscular use only.
Dosage & Administration
DOSAGE AND ADMINISTRATION This product is for intramuscular use only. The use of this product by the intravenous route is not indicated. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. It is important to use a separate vial, sterile syringe, and needle for each individual patient, in order to prevent transmission of infectious agents from one person to another. Any vial of Nabi-HB, Hepatitis B Immune Globulin (Human) that has been entered should be used promptly. Do not reuse or save for future use. This product contains no preservative; therefore, partially used vials should be discarded immediately. Hepatitis B Immune Globulin (Human) may be administered at the same time (but at a different site), or up to one month preceding hepatitis B vaccination without impairing the active immune response to hepatitis B vaccine 11 . Acute Exposure to Blood Containing HBsAg Table 2 summarizes prophylaxis for percutaneous (needlestick, bite, sharps), ocular, or mucous membrane exposure to blood according to the source of exposure and vaccination status of the exposed person. For greatest effectiveness, passive prophylaxis …
Warnings
WARNINGS In patients who have severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections, Nabi-HB, Hepatitis B Immune Globulin (Human), should be given only if the expected benefits outweigh the potential risks. Nabi-HB is made from human plasma. Products made from human plasma may contain infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. The risk that such products can transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current viral infections, and by inactivating and/or reducing certain viruses. The Nabi-HB manufacturing process includes a solvent/detergent treatment step (using tri- n -butyl phosphate and Triton ® X-100) that is effective in inactivating known enveloped viruses such as HBV, HCV, and HIV. Nabi-HB is filtered using a Planova ® 35 nm Virus Filter that is effective in reducing the levels of some enveloped and non-enveloped viruses. These two processes are designed to increase product safety. Despite these measures, such products can still potentially transmit disease. There is al…
Contraindications
CONTRAINDICATIONS Individuals known to have had an anaphylactic or severe systemic reaction to human globulin should not receive Nabi-HB, Hepatitis B Immune Globulin (Human), or any other human immune globulin. Nabi-HB contains not more than 40 micrograms per mL IgA. Individuals who are deficient in IgA have the potential to develop antibodies against IgA and anaphylactic reactions. The physician must weigh the potential benefit of treatment with Nabi-HB against the potential for hypersensitivity reactions.
Drug Interactions
Drug Interactions Vaccination with live virus vaccines should be deferred until approximately three months after administration of Nabi-HB, Hepatitis B Immune Globulin (Human). It may be necessary to revaccinate persons who received Nabi-HB shortly after live virus vaccination. There are no available data on concomitant use of Nabi-HB and other drugs; therefore, Nabi-HB should not be mixed with other drugs.
Adverse Reactions
ADVERSE REACTIONS SECTION Fifty male and female volunteers received Nabi-HB, Hepatitis B Immune Globulin (Human), intramuscularly in pharmacokinetics trials 20 . The number of patients with reactions related to the administration of Nabi-HB included local reactions such as erythema 6 (12%) and ache 2 (4%) at the injection site, as well as systemic reactions such as headache 7 (14%), myalgia 5 (10%), malaise 3 (6%), nausea 2 (4%), and vomiting 1 (2%). The majority (92%) of reactions were reported as mild. The following adverse events were reported in the pharmacokinetics trials and were considered probably related to Nabi-HB: elevated alkaline phosphatase 2 (4%), ecchymosis 1 (2%), joint stiffness 1 (2%), elevated AST 1 (2%), decreased WBC 1 (2%), and elevated creatinine 1 (2%). All adverse events were mild in intensity. There were no serious adverse events. No anaphylactic reactions with Nabi-HB have been reported. However, these reactions, although rare, have been reported following the injection of human immune globulins 23 .
Frequently Asked Questions
What is Nabi-HB used for?
Nabi-HB contains Hepatitis B Immune Globulin (Human). It is a liquid taken intramuscular. Consult your doctor for specific uses.
Is Nabi-HB a controlled substance?
Nabi-HB is not classified as a controlled substance by the DEA.
What is the generic name for Nabi-HB?
The generic name for Nabi-HB is Hepatitis B Immune Globulin (Human). There are 1 other brand versions of Hepatitis B Immune Globulin (Human).
What is the NDC code for Nabi-HB 1560 [iU]/5mL?
The NDC (National Drug Code) for Nabi-HB 1560 [iU]/5mL is 69800-4203, listed by ADMA Biologics, Inc..